510(k) · Cleared
ClearedMam Twister
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mam International AG · KKO Ring, Teething, Fluid-Filled
Cleared on Jun 23, 2010 as substantially equivalent to K052105 (Royal Industries (Thailand) Public Co., Ltd., 2005) after a 286-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Jun 23, 2010
- Review
- 286 days
- Class
- Class II
- Product code
- KKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052105 (2005). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K123855Water-Filled TeetherSolid Toys Ind., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052105 | Water Filled Teether | Royal Industries (Thailand) Public Co., Ltd. | 2005 | — |
| 0 (this device) | K092781 | Mam Twister | Mam International AG | 2010 | — |
| +1 | K123855 | Water-Filled Teether | Solid Toys Ind., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KKO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052105 | Water Filled TeetherSummary page 2…INP, DIDP, DnOP <0,l %), 16 CFR 1500.52(c) - Bite test, EN 71 -I, EN 71-3 & EN 71-9 Predicate device: WATER FILLED TEETHER, ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LT-D. K052105 (a) (4) A description of the device: Class 11Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requ… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123855 | Water-Filled Teether | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K123855 (Solid Toys Ind., Ltd., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KKO devicesKKO Ring, Teething, Fluid-Filled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KKO
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · KKO
240in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKO
1in 2020
MAUDE reports naming product code KKO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 5 | 147 | 2 | 0 |
| 2010 | 4 | 240 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It ik designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092781: Mam Twister.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092781
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026